10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
E. COLI PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORG-9200A
FDA 510(k)
FDA Class 2
·Cardiovascular
PASS LP
FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 29, 2013
MAESTRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·April 26, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·July 23, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014